A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

Trial Information

A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)

- Determine the toxic effects of this regimen in these patients.

- Determine the objective response in patients treated with the established MTD of this regimen.

- Determine time to tumor progression and survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)

Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02)

After chemotherapy, all patients undergo radiotherapy.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will be accrued for this study. (Phase I closed to accrual as of 6/24/02)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme

- Measurable disease

- No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 70-100%

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)

- No known Gilbert's syndrome

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No myocardial infarction within the past 6 months

- No congestive heart failure requiring therapy

Other:

- HIV negative

- No active or uncontrolled infection

- No psychiatric disorder that would preclude study

- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

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